NCT06096714

Addictive Threshold of Nicotine

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

To determine the nicotine threshold dose(s) for discrimination, subjective-rewarding effects, -and reinforcement in smokers with different levels of dependence.

Detailed description

The purpose of this project is to determine the nicotine threshold dose(s) for discrimination, subjective-rewarding effects, and reinforcement in smokers with different levels of dependence. Participants will have an Adaptation Session followed by 4 Test Days. The Adaptation Session will familiarize the participants with study procedures. In each Test Day, a different nicotine dose (0.1, 0.05, 0.025, and 0.0125 mg nicotine/pulse) will be compared to saline for nicotine discrimination, subjective effects, and reinforcement. Participants will first sample the assigned nicotine dose and saline, followed by 4 trials to test their ability to discriminate it from saline. This will be followed by 4 Choice trials where participants will be able to choose between nicotine (at the session-assigned dose) or saline to be administered by the research staff. Reinforcement will be assessed with the percentage of nicotine choices during the Choice trials. The discrimination is the percentage of correctly identified nicotine and saline infusions. Rewarding effects will be assessed with the "Pleasurable Effects" composite score of the Drug Effects Questionnaire (DEQ).

Conditions

• Smoking Addiction

Interventions

Type	Name	Description
DRUG	Nicotine	Nicotine will be infused using a pump.
OTHER	Saline	Saline with be used to compare Nicotine, Saline will be infused using a pump

Timeline

• Start date: 2024-02-27
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2023-10-24
• Last updated: 2025-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study